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Trial Title: Impact of Clinical Evident Portal Hypertension on HCC With TACE (CHANCE-CHESS 2301)

NCT ID: NCT05703750

Condition: Hepatocellular Carcinoma
Portal Hypertension

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Hypertension, Portal
Hypertension

Conditions: Keywords:
hepatocellular carcinoma
transarterial chemoembolization
clinical evident portal hypertension

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Procedure
Intervention name: TACE ± Systemic therapy
Description: TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); Systemic therapy: PD-1/PD-L1 inhibitors, VEGF-TKI/bevacizumab, PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab, radiotherapy or chemotherapy.
Arm group label: CEPH group
Arm group label: non-CEPH group

Summary: The purpose of this study is to discuss the prognostic value of CEPH among HCC patients underwent TACE treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.

Detailed description: Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the second leading cause of cancer-related deaths globally. Transarterial chemoembolization (TACE) is recommended as standard therapy for intermediate-stage HCC according to the current guidelines and is also the most widely used in advanced HCC in real-world practice. Clinically relevant portal hypertension increases the risk of hepatic decompensation, which impairs survival in patients with HCC. The purpose of this study is to discuss the prognostic value of CEPH among HCC patients who underwent TACE treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.

Criteria for eligibility:

Study pop:
Patients with HCC treated with TACE ± Systemic Treatment from June 2006 to December 2021.

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Received at least 1 TACE treatment; Exclusion Criteria: 1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. ECOG Performance Score > 2; 3. History of spleen resection; 4. Loss to follow-up.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Gao-Jun Teng

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Yu-Qing Wang

Facility:
Name: Xiaolong Qi

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Yu-Qing Wang

Start date: May 4, 2023

Completion date: December 31, 2023

Lead sponsor:
Agency: Zhongda Hospital
Agency class: Other

Source: Zhongda Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05703750

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